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Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 27, 2010
Last updated: June 6, 2011
Last verified: June 2011
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.

Condition Intervention Phase
Chronic Hepatitis C
Drug: filibuvir
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Single Sequence Study To Estimate The Effect Of Filibuvir (PF-00868554) On S-And R-Methadone In Subjects Receiving Chronic Methadone Treatment And To Evaluate The Pharmacokinetics Of Filibuvir

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Methadone plasma pharmacokinetic parameters, AUC24, Cmax [ Time Frame: day 1 ]
  • Methadone plasma pharmacokinetic parameters, AUC24, Cmax [ Time Frame: day 11 ]

Secondary Outcome Measures:
  • Methadone plasma pharmacokinetic parameters Tmax and C24h [ Time Frame: day 1 ]
  • Methadone plasma pharmacokinetic parameters Tmax and C24h [ Time Frame: day 11 ]
  • Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. [ Time Frame: day 2 ]
  • Filibuvir plasma pharmacokinetic parameters: Auc 12, Cmax, and Tmax. [ Time Frame: day 11 ]
  • Safety and tolerability, including adverse events, vital signs, 12 lead ECG and lab safety assessments. [ Time Frame: days 0-12 ]
  • Symptoms of methadone withdrawal as assessed by short Opiate Withdrawal Scale, Desires for Drug questionnaire and pupillary diameter measurement . [ Time Frame: days 0-12 ]

Enrollment: 12
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.0 Drug: filibuvir
Filibuvir, 600mg bid administered along with methadone on days 2-11


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Males or females, without evidence of infection with HIV,HBV or HCV, who are on chronic methadone maintenance for at least three months and at a stable dose for at least 1 week prior to study start.

Exclusion Criteria:

  • Evidence of chronic diseases including HIV, HBV or HCV.
  • Evidence of acute or chronic liver disease.
  • Treatment with prescription or nonprescription drugs other than methadone within 7 days.
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Please refer to this study by its identifier: NCT01210404

United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01210404     History of Changes
Other Study ID Numbers: A8121023
Study First Received: September 27, 2010
Last Updated: June 6, 2011

Keywords provided by Pfizer:
Drug interaction with methadone.

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents processed this record on May 25, 2017